Kornimate/medical-research-clean huggingface dataset:
a phase 1 dose escalation and expansion study of shr7280 in subjects with hormone sensitive prostate cancer

Conditions: Hormone Sensitive Prostate Cancer

Summary: this is an open-label, multicenter, dose escalation and expansion phase 1 study of shr7280 in adult patients with hormone sensitive prostate cancer.


Eligibility criteria:
inclusion criteria: 1. ability to understand and the willingness to sign a written informed consent document； 2. age ≥18 years old; 3. histologically or cytologically confirmed prostate adenocarcinoma; 4. candidate for androgen deprivation therapy (adt) for the management of hormone-sensitive prostate cancer； 5. appropriate serum testosterone and serum psa concentration at screening as specified in the protocol； 6. eastern cooperative oncology group (ecog) performance status 0 to 1; 7. adequate organ performance based on laboratory blood tests; 8. agree to use adequate contraception prior to study entry and for the duration of study participation. exclusion criteria: 1. previously received gonadotropin-releasing hormone analogues (gnrh-a) for more than 12 months total duration (if gnrh-a was received for 12 months or less, then that gnrh-a must have been completed washout period prior to the first dose of study drug). 2. patients who have received chemotherapy for prostate cancer; 3. history of surgical castration; 4. received abiraterone acetate with 3 months prior to the first dose of study drug; 5. receieved molecular target therapy, immunotherapy, androgen receptor blockade, 5-alpha reductase inhibitors, estrogen, and other investigational compound with 4 weeks prior to the first dose of study drug; 6. patients with known or suspected brain metastasis； 7. diagnosis or treatment for another systemic malignancy within 5 years before study treatment initiation; 8. patients with uncontrolled and clinically significant hypertension and diabetes; 9. known hypersensitivity to shr7280, shr7280 excipients,； 10. history of immunodeficiency (including hiv infection) or organ transplantation; 11. known active hepatitis b or c infection; 12. other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
postextubation high-flow therapy vs noninvasive ventilation in obese or at high-risk patients

Conditions: Extubation Failure

Summary: the main aim is to demonstrate whether reintubation rate is lower with preventive conditioned noninvasive ventilation (niv) rather than with high-flow oxygen therapy (hfot) in obese intermediate-risk patients and in high-risk patients.


Eligibility criteria:
inclusion criteria: 1. high-risk patients: patients under mechanical ventilation for more than 24 hours considered at high risk according to the presence of more than 3 of the following risk factors: * \>65 years. * cardiac failure as the primary indication of mechanical ventilation. * moderate to severe chronic obstructive pulmonary disease. * apache ii \>12 points the extubation day. * body mass index \>30. * inability to manage respiratory secretions. * not simple weaning. * more than 1 comorbidity. * more than 7 days under mechanical ventilation. * hypercapnia during the spontaneous breathing trial. * airway patency problems. 2. obese intermediate risk patients: patients under mechanical ventilation for more than 24 hours with a body mass index \>30 and considered at intermediate risk according to the presence of less than 3 of the following risk factors: * \>65 years. * cardiac failure as the primary indication of mechanical ventilation. * moderate to severe chronic obstructive pulmonary disease. * apache ii \>12 points the extubation day. * inability to manage respiratory secretions. * not simple weaning. * more than 1 comorbidity. * more than 7 days under mechanical ventilation. * airway patency problems. exclusion criteria: * \<18 years. * thacheotomized patients. * contraindications for niv (recent facial or cervical trauma/surgery, active gastro-intestinal bleeding, lack of cooperation). * unscheduled extubation. * do not reintubate orders. * no informed consent.
assessment of handwriting skills in a sample of egyptian children with attention-deficit hyperactivity disorder

Conditions: Attention Deficit Disorder with Hyperactivity (ADHD)

Summary: purpose: to assess handwriting difficulties in adhd children. background: attention deficit hyperactivity disorder (adhd) is one of the most common neurodevelopmental disorders that affects 7.6% of children worldwide. in addition to the core symptoms defining attention-deficit/hyperactivity disorder (adhd), adhd children often experience motor problems, including graphomotor movements, leading to handwriting difficulties. studies have confirmed that handwriting skills are adversely impacted by the presence of adhd, and this is associated with lower academic achievement and self-esteem. children with adhd have been found to display greater difficulties in the development of motor coordination, especially in the planning and execution of complex, lengthy, and novel chains of goal-directed behavior. also, handwriting problems in adhd may signal underlying executive function deficits such as inhibition, emotional dysregulation, working memory problems, and difficulty with self-monitoring, all of which are required for various daily functions beyond handwriting per se. with a slower motor response and perceptual speed, these deficits may decrease the likelihood that a child with adhd can work efficiently and stay on-task during school and home activities.

written informed consents will be obtained from the parents of participants. all participants will undergo the following: 1. thorough history taking and medical examination. 2. anthropometric measurements: weight, height 3. diagnosis by dsm 5 4. conners' parent rating scales-revised (cprs-r) to assess the severity of adhd symptoms. 5. intelligence quotient (iq) test: stanford binet intelligence scale, fifth edition to assess the mental ages of the children and measure their intelligence quotients. 6. assessment of handwriting using (handwriting legibility scale (hls) to evaluate the handwriting skills of the participants including ...... 7. assessment of neuropsychological abilities related to executive functioning and learning using the learning, executive, and attention functioning (leaf) scale. 8. language assessment to identify any underlying language deficits that might contribute to handwriting difficulties. 9. a baseline mechanical gauge was used to measure palmer pinch strength in kilograms 10. a baseline mechanical gauge was used to measure hand grip strength in kilograms 11. statistical analysis using the spss version 22.

Eligibility criteria:
inclusion criteria: * adhd children can read and write * both sexes. exclusion criteria: * low iq children

Keywords: adhd handwriting skills
a retrospective comparison between cps and hc techniques for osteoporotic fractures in the thoracic or lumbar spine

Conditions: Osteoporosis

Summary: cement-augmented pedicle screws (cps) and hybrid construct (hc) consisting of pedicle screws and additional hooks are common methods in osteoporotic fracture of the thoracic and lumbar spine. no study has compared the surgical results between cps and hc techniques for treatment of the osteoporotic thoracic and lumbar spine fracture. the aim of the retrospective study was to compare surgical results using cps or hc for osteoporotic fractures in the thoracic or lumbar spine. patients who received surgical treatment with cps or hc for osteoporotic fractures in the thoracic or lumbar spine.

osteoporosis, the most common metabolic bone disease, leads to alteration of bone density that has been shown to compromise the strength of spinal instrumentation. with elderly populations growing, rates of spine surgery performed on osteoporotic patients have increased to treat a variety of conditions. vertebral fracture is the most common osteoporotic fracture in the elderly, and surgical intervention is sometimes needed for patients who are diagnosed as nonunion, failure of vertebroplasty, and neurologic deficits. therefore, spine surgeons will increasingly face the challenge of achieving rigid fixation of osteoporotic spines. cement-augmented pedicle screws are the most common strategy to maximize pullout strength for fixation of osteoporotic spines. hybrid constructs, a combination of pedicle screws and hooks, offer an alternative approach to avoid implant failure and increasing construct stability when placing instrumentation in the osteoporotic spine. biomechanical studies of either cement-augmented pedicle screws or combined pedicle screws and hooks for osteoporotic spine have demonstrated superior results compared to pedicle screws only in terms of improving implant pullout strength. however, few clinical investigation to date has focused on comparing surgical results of the cement-augmented pedicle screws (cps) and hybrid construct (hc) techniques. the goal of the retrospective cohort study was to compare the surgical outcomes and surgery-, patient- and implant-related complications between the cps and hc techniques for osteoporotic vertebral fractures in the thoracic or lumbar spine.

Eligibility criteria:
inclusion criteria: * surgical treatment with cps or hc of pedicle screws and hooks for osteoporotic fractures in the thoracic or lumbar spine * received a minimum of 2-year follow-up exclusion criteria: * t-scores greater than -2.5 * cancer metastasis * chronic osteomyelitis * failure to complete the questionnaires or radiographic examinations

Keywords: thoracolumbar fracture cement augmentation hook pedicle screw hybrid construct
role of probiotics as adjunct therapy along with standard care in decreasing hospital stay and improving symptoms in pediatric patients admitted with severe pneumonia

Conditions: Pneumonia; Probiotics

Summary: probiotics as adjuvant therapy along with standard care can decrease hospital stay and improve symptoms (fever, tachypnea,cough) in pediatric patients admitted with severe pneumonia.

after getting written informed consent from parents/attendants, all patients aged 6 month-2yrs admitted with severe pneumonia in pediatric wards of children hospital, during the study time of 6 month will be recruited.after applying exclusion criteria remaining participants will be included in the study. the study population will be randomized in to two groups, group a will be given probiotic sachet and group b will be given simple milk as placebo.the patients and their parents/attendants will be kept blind to the fact that they are receiving either probiotic or placebo the probiotic and placebo mixture will be given daily for three days.the patients in both the groups will be followed for the duration of illness until they are either discharged or show any adverse outcomes of pneumonia.total days of admission will be recoded for patients discharged from hospital.parents will be asked questions regarding improvement in symptoms like fever on discharge. duration for improvement in tachypnea andcough will be noted for all patients. outcomes will be duration of hospital admission, improvement in fever, tachypnea and cough.all the data collected will be entered and analyzed using spss latest version and analysed.

Eligibility criteria:
inclusion criteria patient aged 2month-24months. both male and female children exclusion criteria: patients with severe acute malnutrition patients with very severe pneumonia patients with other concurrent infections patients having any chronic debilitating condition children who took probiotics in past 6 months patient requiring mechanical ventilation

Keywords: pneumonia treatment probiotics
structured personalized oxygen and supportive therapies for dyspnea in oncology

Conditions: Dyspnea

Summary: to learn about the effect of structured personalized oxygen and supportive therapies for dyspnea in oncology (spot-on) treatment on the severity of shortness of breath in patients with cancer.

primary objectives: 1. to determine the effect of spot-on and enhanced usual care on the change in intensity of dyspnea (nrs) between baseline and 24 h in hypoxemic hospitalized patients with cancer. 2. to determine the effect of spot-on and enhanced usual care on the change in intensity of dyspnea (nrs) between baseline and 24 h in non-hypoxemic hospitalized patients with cancer. secondary objectives: 1. to determine the effect of spot-on and enhanced usual care on patient outcomes over 72 h, including intensity of dyspnea (nrs), unpleasantness of dyspnea (nrs), dyspnea response, ital signs, symptom burden, health-related quality of life (eq-5d-5l), adverse events, patterns of device use, and hospital outcomes. 2. to identify factors associated with dyspnea response in the spot-on intervention, including patient demographics, preferences, and level of usage of oxygen delivery modalities. 3. to identify patient factors associated with their preferences (after phase ii and phase iii) for each of the oxygen delivery modalities in the spot-on intervention, such as patient demographics and dyspnea characteristics.

Eligibility criteria:
inclusion criteria: * diagnosis of advanced cancer (metastatic, locally advanced, recurrent, or incurable). * age 18 or older. * admitted to a medical floor. * dyspnea intensity at rest of at least 4 on a 0-10-point nrs (where 0 = none, 10 = worst). * speak english or spanish. exclusion criteria: * hemodynamic instability requiring active merit team or icu team involvement. * delirium as per clinical team's assessment in the electronic health record (ehr). * severe hypoxemia (spo2 \< 90% despite supplemental oxygen of up to 6 l/min). * continuous positive airway pressure (cpap) use for obstructive sleep apnea, actively using \>10 hours a day. * respiratory failure necessitating mechanical ventilation (i.e., hfnc or niv), and planned thoracentesis within 72 hours of enrollment. * patients with known pregnancy.
ocular surface disorders in patients in intensive care units, a comparative study of three preventive approaches

Conditions: Corneal Diseases

Summary: 60% of the patients hospitalized in intensive care and sedated suffer from insufficient inferior eyelid occlusion. thus, they are at risk for corneal damage (estimated risk 20% to 57%). the prevention of such corneal damage can be done using several techniques (artificial tears, eyelid occlusion dressing, aqueous gel). the efficacy of these techniques has never been compared in a rigorous study. therefore it is not yet possible to determine an evidence-based strategy to prevent corneal damage in intensive care patients. this study aims at assessing the efficacy of primary prevention of corneal lesions in intensive care patients, in order to elaborate an evidence-based nursing protocol.


Eligibility criteria:
inclusion criteria: * adult patient * hospitalized in an intensive care unit * tracheal intubation and mechanical ventilation since less than 24 hours, with an expected duration of artificial ventilation superior to 72h exclusion criteria: * patient currently treated by eyedrops for glaucoma * antecedent of corneal transplant * ocular prosthesis

Keywords: intensive care corneal damage prevention nursing protocol
stapler-less burst pressure in a ex-vivo human gastric tissue

Conditions: Obesity, Morbid; Suture, Complication; Suture Rupture

Summary: stapler-less laparoscopic sleeve gastrectomy (lsg) is emerging as a new potential affordable cost-effective alternative procedure. however, no pre-clinical data are currently available on human tissue. we aimed to evaluate whether traditionally suturing without the use of surgical stapling may produces a comparable bursting pressure on human gastric tissue.

stapler-less laparoscopic sleeve gastrectomy (lsg) is emerging as a new potential affordable cost-effective alternative procedure. however, no pre-clinical data are currently available on human tissue. we aimed to evaluate whether traditionally suturing without the use of surgical stapling may produces a comparable bursting pressure on human gastric tissue. a prospective cohort of consecutive patients underwent lsg was divided in two groups to compare a barbed extramucosal running suture (stapler-less) versus a standard stapler line. a burst pressure test was applied to the gastric specimen employing high-resolution manometric catheter. type, location and features of the leak were described. in human ex-vivo model, traditional surgical suture (i.e. running hand-sewn) produced an effective temporary closure, with superior resistance to increasing volume and pressure. how this may impact on clinical lsg outcomes needs further evaluations and was not the object of this study.

Eligibility criteria:
inclusion criteria: * morbid obesity according to ifso guidelines exclusion criteria: * gastric specimen with injury and/or electrocoagulation signs at serosa * presence of comorbidities capable of affecting specimen tissue resistance (i.e. type ii diabetes, gastric ulcer, connective tissue disease, systemic sclerosis, polymyositis)

Keywords: sleeve gastrectomy stapler-less burst pressure leaks
postoperative biliary fistula prevention after hepatectomy

Conditions: Hepatectomy

Summary: aim : effect of external biliary duct stent after hepatectomy on the occurence of postoperative biliary fistula. methods : french prospective multicenter randomized trial. population study: adult patients who underwent hepatectomy (\> 2 segments) on non-cirrhotic liver. hypothesis: decreased postoperative biliary fistula from 15% to 5% with the presence of a external biliary duct stent. with this hypothesis, the number of patients required to be equal to 152 per group for a total of 304 patients. outcome measure: primary : postoperative biliary complications (biliary fistula, biloma, biliary peritonitis) secondary : all morbidity, mortality, additional manoeuvres to treat biliary fistula, during of hospital stay and biliary fistula. follow up: a follow-up of patients 3 months after surgery for all patients. the planned total duration of the study is 3 years and 3 months.

after performing the hepatectomy and verification of hemostasis, patients were randomized (external biliary duct stent or not) by sealed envelopes. systematic intraoperative test with methylene blue or air by the external biliary duct stent (ebds) will necessary for all patients. intra-abdominal drainage or not and type will be at the discretion of the surgeon. the ebds will be left open for the first 7 postoperative days and then clamped. the ebds will be removed during a consultation 5 weeks after surgery. both groups of patients will be reviewed at 3 months after surgery, it will be noted at this point the possible complications related to the presence of ebds (leakage from the drain, drop..). if patients are hospitalized more than five weeks, the study will stop at their consultation three months or the day of the consultation where the dtc is removed if it is still present at 3 months.

Eligibility criteria:
inclusion criteria: * subject has given his informed consent and signed consent * hepatectomy at least 2 segments of liver parenchyma for a benign or malignant disease by laparotomy * not cirrhotic liver exclusion criteria: * surgery made in emergency * surgery by laparoscopy * need to draw up a bilic-digestive anastomosis * liver cirrhosis * history of cholecystectomy * resection of less than 2 segments * preoperative jaundice (total bilirubin\> 30 micromol / l) * presence of preoperative biliary drainage * patients requiring the installation of a drain transcystic during the operation

Keywords: biliary fistula prevention hepatectomy external stent hepatectomy of more 2 segments not emergency or laparoscopy surgery
alcohol intake, alcohol metabolizing enzymes gene polymorphisms and the risk of colorectal cancer

Conditions: Colorectal Neoplasms

Summary: according to the statistic reports from world health organization (who) international agency for research on cancer (iarc), the incidence and mortality rate of colorectal cancer ranked third and fourth respectively among ten most commonly diagnosed cancer worldwide; moreover, based on the statistics from health promotion administration, ministry of health and welfare in taiwan, the incidence and mortality rate of colorectal cancer ranked second and third respectively among call cancer in taiwanese population. however, if colorectal cancer is diagnosed and treated in early phase, the 5-year survival rate for stage i colorectal cancer can be up to 90%; on the other hand, the 5-year survival rate for end stage colorectal cancer is only approximately 10%. therefore, the screening, early diagnosis od colorectal cancer is crucial. to date, there are some known risk factors for colorectal cancer, including familial adenomatous polyposis, obesity, physical inactivity, etc. alcohol had also been identified as an important risk factor for colorectal cancer, and the risk could be higher among asian population because of the reduced enzymatic activity of some of the alcohol metabolizing enzymes. thus, through this study, the investigators hope to find out the risk factors of colorectal cancer among taiwanese population, including alcohol metabolizing enzyme gene polymorphisms and their interaction with environmental factors, to attain the purpose of early prevention of colorectal cancer.

the purpose of this study is to find out relationship between alcohol metabolizing enzyme gene polymorphism and colorectal cancer, and discuss the impact of the interaction between gene polymorphism and environmental factors on the risk of colorectal cancer.

Eligibility criteria:
inclusion criteria: case: * histologically confirmed colorectal adenocarcinoma at national taiwan university hospital (ntuh) from 2000 to 2016 * age \>20 at the time of inclusion control: * no diagnosis of colorectal cancer * age \>20 at the time of inclusion * family members of case, including parents, siblings, offspring, spouse mother-in-law or daughter-in-law exclusion criteria (both for case and control): * history of familial adenomatous polyposis * history of partial or total removal of the colorectum * history of inflammatory bowl disease * history of malignant neoplasms

Keywords: alcohol gene polymorphisms colorectal cancer